The following data is part of a premarket notification filed by Birtcher Corp. with the FDA for Model 375 Ecg.
| Device ID | K881328 |
| 510k Number | K881328 |
| Device Name: | MODEL 375 ECG |
| Classification | Electrocardiograph |
| Applicant | BIRTCHER CORP. 4501 N. ARDEN DR. P.O. BOX 4399 El Monte, CA 91731 |
| Contact | Donald L Emmons |
| Correspondent | Donald L Emmons BIRTCHER CORP. 4501 N. ARDEN DR. P.O. BOX 4399 El Monte, CA 91731 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-29 |
| Decision Date | 1988-05-18 |